Retaining clip for catheter sheath

ABSTRACT

Disclosed herein is a retaining clip for the sheath used to protect a catheter tube from contamination during insertion of the guiding needle. The clip is designed to snap over the hub of the needle and at the same time clasp the mouth of the sheath about the hub. The clip includes a curved body portion and a pair of curved depending legs. An upturned neck extends from the body portion to facilitate removal of the clip after the needle has been inserted.

United States Patent Scislowicz 1 June 27, 1972 [54] RETAINING CLIP FORCATHETER SHEATH [72] inventor: Henry M. Scislowicz, Lake Bluff, ll].[73] Assignee: Abbott Laboratories, North Chicago, Ill. [22] Filed: May25, 1970 211 Appl. No.: 40,010

[52] US. CL, ..l28/2l4.4, 128/221, 128/349 [51] Int. Cl. ..A6lm 5/00[58] Field ofSearch ..128/2l4,214.2,2l4.4, 348,

128/349, 350, 276, 262; 206/632; 24/11 PP, 259 FF, 243M, 11 CT, 257 R 56] References Cited UNITED STATES PATENTS 3,215,141 11/1965 Podhora..128/2l4.4 1,120,549 12/1914 Schellberg ...206/63.2 X 2,915,063 12/1959Cutter ..128/214.4

3,050,060 8/1962 Hoffman 128/262 UX 3,084,693 4/1963 Cathcart....,..l28/262 X 3,506,011 4/1970 Silverman 128/348 FOREIGN PATENTS ORAPPLICATIONS 1,513,360 1/1968 France ..l28/2l4.4

Primary Examiner-Dalton L. Truluck Assistant Examiner-J. C. McGowanAttorneySherman and Shalloway [57] ABSTRACT Disclosed herein is aretaining clip for the sheath used to protect a catheter tube fromcontamination during insertion of the guiding needle. The clip isdesigned to snap over the hub of the needle and at the same time claspthe mouth of the sheath about the hub. The clip includes a curved bodyportion and a pair of curved depending legs. An upturned neck extendsfrom the body portion to facilitate removal of the clip after the needlehas been inserted.

7 Claims, 7 Drawing Figures PATENTEDmzv 1972 saw 10F 2 INVENTOK HENRY M.SCISLOWICZ Ska/MM @AWW ATTORN EYS 1 RETAINING cur FoR CATHETERSI-IEATI-I This invention relates to an intravenous catheter and inparticular to a clip structure for retaining a protective sheath overthe catheter tube during venipuncture.

During the administration of parenteral liquids, as by intravenousfeeding, one of the more standard procedures is to make a venipuncturewith a cannula and then thread a sterile plastic catheter into the vein.During the venipuncture, the shank end of the catheter extends from theshank end of the cannula and may be exposed to contamination. It hasbeen an accepted practice to .protect the shank of the catheter fromsuch contamination by maintaining the protective casing or envelope inwhich the device is packaged over the extension of the catheter duringthe venipuncture. However, this type of operation has proved awkward andprovides basis for needed improvement in means to maintain the catheterfree from contamination during its use.

After the venipuncture is complete and the catheter is threaded throughthe cannula into the vein, the cannula is then withdrawn and thecatheter may be taped to the patients body approximate the entry point.Subsequently, an administration apparatus is attached to the catheterand the intravenous feeding of the patient may commence.

The above-described basic operation is well known and a number ofapparatus have been provided for the practice. A particularly suitabledevice has been described in US. Pat. No. 3,323,523 and reference may bemade to that disclosure for a complete description of the background towhich this invention relates.

By way of summary, the present invention provides an improvedintravenous catheter unit which includes a protective sheath mountedover the shank end of the catheter tube and connected to the hub of thecannula needle. This sheath is loosely mounted on the hub of the cannulaneedle and serves to prevent contamination of the shank end of thecatheter tube during insertion of the needle. A primary aspect of thepresent invention is directed to a clip for securing the sheath to thehub of the needle, but which permits a simple and quick removal of thesheath.

The catheter device of the present invention is packaged in atransparent casing or envelope and the entire assembly is sterilized inthe envelope after packaging. Arrangements of this type have previouslyemployed the envelope as a means for protecting against contaminatingthe shank end of the catheter tube. However, this arrangement has provedunsatisfactory in that a somewhat cumbersome and awkward manipulation ofthe device is required.

The present invention avoids these problems and has as its primaryobject the provision of a loosely fitting-sheath over the shank end of acatheter tube with removable retaining means for holding the sheath inengagement with the shank of the cannula needle.

Another object of this invention is to provide a clip for holding thesheath on the hub of the cannula needle, which clip is constructed of aresilient flexible material which can be quickly snapped off the hub ofthe needle.

The primary object of the invention having been stated, other objects ofthe invention will become apparent to those skilled in the art whenreference is made to the following detailed description of oneembodiment of the invention.

This description is made in conjunction with the accompanying drawingswherein:

FIG. 1 is a side elevation view of the intravenous catheter of thepresent invention in assembled relation and enclosed in a transparentenvelope;

FIG. 2 is a fragmentary perspective view showing the arrangement of thecatheter device immediately after venipuncture;

FIG. 3 is a fragmentary perspective view showing the device immediatelyafter placement of the catheter tube;

FIG. 4 is a fragmentary perspective view showing the catheter deviceafter removal of the cannula needle;

FIG. 5 is a fragmentary perspective view showing the final arrangementof the device connected for intravenous feeding;

FIG. 6 is a cross-sectional view taken along the line 6-6 of FIG. 2; and

FIG. 7 is a perspective view of the clip of the present invention.

Referring now to FIG. 1, the packaged unit is illustrated. The catheterassembly is generally indicated at 10 and includes the cannula needle 12having a hub 14 and the catheter tube 16 extending therethrough.

For convenience of description, the cannula needle is shown to include apointed end 18 and the base end 20. The catheter tube includes a tip 22and a shank end 24.

Extending about and surrounding the shank end 24 of the catheter tube isthe sheath 26. The sheath 26 fits loosely over the hub 14.

Connecting the sheath 26 at its mouth portion 28 to the hub 14 is theclip indicated generally at 30. The relative sizes of the mouth of thesheath 26 and the outside diameter of the hub 14 are such that thesheath could be easily removed from the hub of the needle. Thisarrangement is important to recognize since, when it is time to removethe sheath 26 from the assembly, it is highly impractical to have anyfrictional engagement between the mouth 28 and the hub 14. Such africtional engagement would require some twisting and manipulation ofthe sheath 26 to remove it. On the other hand, the arrangement andconstruction of the device as presently described permits the sheath tobe readily removed and thus does not require any movement or twisting ofthe assembly which might result in an unnecessary injury to the patient.The clip 30 is designed to grip and hold the mouth 28 about the hub 14and this relationship can be seen clearly in FIG. 6.

The clip 30 is constructed of a plastic or other spring type materialwhich permits same to clasp the mouth of the sheath 26 firmly about thehub 14. When it comes time to remove the sheath 26 from the assembly,the clip 30 can be easily removed from the hub 14 by merely placing afinger under the neck 32 and snapping off the clip. At this point, thesheath may be easily removed.

Referring again to FIG. 1, it can be seen that the catheter tube 16 hastelescopically fitted therein a flexible stiffener 34. The stiffener 34is designed to assist in the guiding and insertion of the catheter tubein the patients vein after the venipuncture is made. Finally, the entireassembly is shown enclosed in a transparent casing or envelope 36, whichis made of a thin, flexible plastic material.

After the assembly has been completed, and the assembly is packaged inthe envelope 36, the unit is sterilized in its packaged condition. Byhaving the sheath 26 fitting loosely about the hub 14 of the needle, itis clear that the sterilization process permits sterilization of theentire unit, including the shank 24 of the catheter tube and that theprimary purpose of the sheath 26 is to avoid contamination of the shank24 once the envelope 36 has been removed and the device is beinginserted in the patients body.

As can be further seen from FIG. I, the base end of the cannula needle12 is counterbored at 38 for receiving adapter 40 mounted on the shank24 of the catheter tube when the catheter is passed through the cannulaneedle into the patient's vein.

It can also be seen from FIG. 4 that the shank 24 includes an enlargedportion 42 which is counterbored at 44 for receiving the adapter 46 onthe base end of the flexible stiffener 34.

Once the device has been inserted in the patient and the catheter tubeis in the patients vein, and the device is ready for connection to theadministration set for the intravenous feeding, the counterbore 44 willreceive an adapter provided on the end of the tube of the administrationset (see FIG. 5).

Referring now to FIGS. 2-5, the use of the device employed in thepresent invention is illustrated. FIG. 2 shows the catheter assembly 10after the envelope 36 has been removed and the venipuncture made. FIG. 2clearly shows the protective sheathing 26 covering the shank 24 of thecatheter tube to protect the shank from contamination by the user duringvenipuncture. As shown in phantom lines in FIG. 2, the sheath 26 mayinclude a bulbous portion 26 as an alternative construction of thesheath. The alternative construction employing the bulbous portion 26'may be molded to include the thinned portions 48 for a purpose whichwill be described shortly.

The clip 30 still retaining the sheath 26 securely about the hub 14 ofthe needle, the device now has the catheter tube 16 passed through thecannula needle 12 into the patient's vein, as can be seen in FIG. 3.This is accomplished by holding the needle hub securely in the positionas shown in FIG. 2 and applying pressure to the base end 50 of theassembly. This pressure forces the cannula tube and the stifiener member34 through the bore of the needle 12. The pressure also causes thesheath 26 to collapse and if a sheath construction of the alternativetype illustrated in FIG. 2 is provided, the sheath will collapse in apredetermined pattern as defined by the thinned portions 48, which ineffect constitute fold lines extending annularly about the sheath.

Referring now to FIG. 4, the device is illustrated with the parts intheir relation after the cannula needle 12 has been withdrawn from thepatients body. The catheter tube 16 will remain in communication withthe patients vein, as is shown. The needle 12 is withdrawn by merelywithdrawing the entire assembly a sufficient distance to disengage theneedle from the patient. The initial insertion of the catheter tube 16is of sufficient depth so that when the needle 12 is withdrawn, asignificant portion of the tip 22 of the catheter tube is left withinthe patient's vein.

After the needle 12 has been withdrawn from the patient, the flexiblestiffener 34 will be removed from the device by holding the enlargedportion 42 of the shank 24 of the catheter tube and grasping ,the baseend of the stiffener through the flexible sheath 26 to withdraw thestiffener. This step has already been performed in the relation of theparts as shown in FIG. 4.

The next step of the procedure is to remove the clip 30 by holding theassembly adjacent the base end 20 and at the same time placing a fingeror thumb under the neck 32 of the clip and springing the clip off theassembly. The sheath 26 is then free to be easily removed from theassembly and the assembly is made ready for connection to theadministration set merely by grasping the stiffener 34 approximate itsbase end and the closed end of the sheath at the same time and applyinga removing force. Since the sheath 26 fits loosely about the hub 14 atits mouth 28, there is no need for any twisting or other manipulation ofthe device to overcome frictional or other connecting forces. This stephas been completed in the arrangement of the assembly shown in FIG. andthe device has been connected to the administration set by means of theadapter 52 fitted within the counterbore 44. The adapter 52 is providedon the end of the tube 54 which is shown schematically connected to anadministration set 56.

Referring now to FIG. 7, one embodiment of the construction of the clipof the present invention is illustrated. This clip includes the body 60having the upwardly curved neck portion 32 and the depending legs 62 and64, the body and legs defining a gripping surface adapted to extendgreater than 180 but less than 360 around the hub 14 of needle 12. Thelegs are curved and subtend the major portion ofa circle with theconcave segment of each of the curved legs facing each other. As will bereadily understood, the clip 30 is of a highly resilient spring typematerial and may be readily snapped over or snapped off of the hub 14carrying the mouth 28 of the sheath 26. This arrangement can be seen inFIG. 6, which shows the clip 30 forcing the mouth 28 tightly about thehub 14.

The primary advantages of the assembly illustrated, including the clipof the present invention, are that the sheath 26 is secured to theneedle 12 to avoid contamination of the catheter tube 16 duringsubstantially the entire period of venipuncture and connection of thedevice to the administration set. Moreover, this protection againstcontamination does not provide any type of a hindrance when the initialsterilization of the assembly is accomplished after the device has beenpackaged in the envelope 36 since the connection between the mouth 28and the hub 4 IS discontinuous, as is shown in FIG.

6. The provision of thinned or weakened portions on the sheath 26permits a controlled folding or collapsing of the sheath during themanipulation of the device so that no significant pressure will beapplied to the clip 30. Finally, once the assembly has been inserted andjust prior to the time for connection to the administration set, theclip 30 may be sprung from the assembly by a minimum amount of pressureapplied under the neck 32. Removal of the clip 30 permits the sheath 26and the flexible stifiener 34 to be readily removed from the devicewithout the need for any twisting or significant manipulation of theassembly to overcome any frictional forces which might otherwise beconnecting the sheath to the needle. This easy removal of the sheath 26ensures that unnecessary injury to the patient can be avoided and at thesame time simplifies the use of the catheter device over the proceduresinvolved in the use of prior art structures.

A detailed description having been given of exemplary embodiments of thepresent invention, the true nature and scope of the invention is definedin the appended claims.

I claim:

1. In a catheter assembly including a needle having a hub on one endthereof, a passage extending through the entire length ofsaid needle, acatheter tube within said passage and extending from said needle at thehub end thereof, and a sheath over the extension of said catheter tube,the improvement including: said sheath having a mouth fitted looselyabout the hub of said needle and a clip removably securing said sheathto said hub, said clip having a configuration to mate with said hub anddefining a gripping surface extending greater than but less than 360around said hub, said clip having a laterally extending portion tofacilitate removal of said clip.

2. A catheter assembly as defined in claim 1 wherein said clip includesa body having a pair of depending curved legs with concave surfacesfacing each other, the body and legs in combination defining the arc ofa circle greater than 180 but less than 360.

3. A catheter assembly as defined in claim 2 wherein said laterallyextending portion includes an upturned neck extending from said body.

4. A catheter assembly as defined in claim 1 wherein said sheath istubular and has a bulbous segment mediate its ends.

5. A catheter assembly as defined in claim 4 wherein said tubular sheathhas weakened sections circumferentially thereabout at each end of saidbulbous segment.

6. A catheter assembly as defined in claim 4 wherein said sheath isclosed at an end opposite from said mouth.

7. A catheter assembly as defined in claim 3 wherein said clip isconstructed of a flexible plastic material.

1. In a catheter assembly including a needle having a hub on one endthereof, a passage extending through the entire length of said needle, acatheter tube within said passage and extending from said needle at thehub end thereof, and a sheath over the extension of said catheter tube,the improvement including: said sheath having a mouth fitted looselyabout the hub of said needle and a clip removably securing said sheathto said hub, said clip having a configuration to mate with said hub anddefining a gripping surface extending greater than 180* but less than360* around said hub, said clip having a laterally extending portion tofacilitate removal of said clip.
 2. A catheter assembly as defined inclaim 1 wherein said clip includes a body having a pair of dependingcurved legs with concave surfaces facing each other, the body and legsin combination defining the arc of a circle greater than 180* but lessthan 360* .
 3. A catheter assembly as defined in claim 2 wherein saidlaterally extending portion inclUdes an upturned neck extending fromsaid body.
 4. A catheter assembly as defined in claim 1 wherein saidsheath is tubular and has a bulbous segment mediate its ends.
 5. Acatheter assembly as defined in claim 4 wherein said tubular sheath hasweakened sections circumferentially thereabout at each end of saidbulbous segment.
 6. A catheter assembly as defined in claim 4 whereinsaid sheath is closed at an end opposite from said mouth.
 7. A catheterassembly as defined in claim 3 wherein said clip is constructed of aflexible plastic material.